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Comparing Efficacy and Safety of Enlituo® Versus Erbitux® Plus FOLFOX in Locally Advanced/Metastatic Colorectal Cancer With RAS/BRAF Wild-type and MSS/pMMR Status.

NCT07595276 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 608

Last updated 2026-05-19

No results posted yet for this study

Summary

This is a randomized, double-blind, phase III clinical trial. The study aims to demonstrate that the treatment regimen of Enlituo® plus FOLFOX is equivalent to that of Erbitux® plus FOLFOX in participants with RAS/BRAF wild-type and MSS/pMMR locally advanced/metastatic colorectal cancer.

Enrolled participants will be stratified according to ECOG performance status (0 vs. 1) and primary tumor location (left-sided or right-sided colon) and randomly assigned in a 1:1 ratio to either the experimental group (Enlituo® + FOLFOX) or the control group (Erbitux® + FOLFOX).

Participants will:

* Receive Enlituo®/Erbitux®: 500 mg/m², administered via intravenous infusion over a minimum of 120 minutes, once every two weeks.
* Receive FOLFOX
* Participants in the Erbitux® plus FOLFOX group who achieve CR, PR, or SD at 16 weeks will cross over to receive Enlituo® plus FOLFOX.
* Be recommended to undergo efficacy assessments every 8 weeks (±7 days).
* Comply with the blood sample collection procedures for pharmacokinetic (PK) and immunogenicity analyses.
* Be required to provide baseline tumor biopsy specimens or 8-10 unstained slides of archived tumor tissue (formalin-fixed, paraffin-embedded) from within the past 3 years.

The Blinded Independent Central Review (BIRC) will assess:

* Objective Response Rate (ORR) within 16 weeks.
* Disease Control Rate (DCR) within 16 weeks.
* Duration of Response (DoR).
* Progression-Free Survival (PFS).

The investigators will assess:

* ORR within 16 weeks.
* DCR within 16 weeks.
* DoR.
* PFS.
* Overall Survival (OS).
* Safety: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), as well as findings from laboratory tests, vital signs, and physical examinations.
* Dose intensity, and incidence of dose interruptions, dose reductions, and treatment discontinuations due to AEs.

Conditions

Interventions

BIOLOGICAL

Enlituo®

Enlituo®: 500 mg/m², administered via intravenous infusion over a minimum of 120 minutes, once every two weeks. FOLFOX Regimen: Oxaliplatin: 85 mg/m², administered via intravenous infusion over 2 hours, on Day 1 of each treatment cycle. One treatment cycle spans 2 weeks. Leucovorin (LV): 400 mg/m², administered via intravenous infusion over 2 hours, on Day 1 of each treatment cycle. One treatment cycle spans 2 weeks. 5-Fluorouracil (5-FU): Bolus: 400 mg/m², administered via intravenous bolus, on Day 1 of each treatment cycle. Continuous Infusion: 1200 mg/(m²•day) for 2 days (total dose 2400 mg/m²), administered via continuous intravenous infusion over 46 to 48 hours, on Days 1 to 3 of each treatment cycle. One treatment cycle spans 2 weeks.

BIOLOGICAL

Erbitux®

Erbitux®: 500 mg/m², administered via intravenous infusion over a minimum of 120 minutes, once every two weeks. Erbitux® will be administered for up to 16 weeks. Participants who continue to derive benefit (including SD, PR, and CR) after 16 weeks will crossover to receive Enlituo® combined with FOLFOX. FOLFOX Regimen: Oxaliplatin: 85 mg/m², administered via intravenous infusion over 2 hours, on Day 1 of each treatment cycle. One treatment cycle spans 2 weeks. Leucovorin (LV): 400 mg/m², administered via intravenous infusion over 2 hours, on Day 1 of each treatment cycle. One treatment cycle spans 2 weeks. 5-Fluorouracil (5-FU): Bolus: 400 mg/m², administered via intravenous bolus, on Day 1 of each treatment cycle. Continuous Infusion: 1200 mg/(m²•day) for 2 days (total dose 2400 mg/m²), administered via continuous intravenous infusion over 46 to 48 hours, on Days 1 to 3 of each treatment cycle. One treatment cycle spans 2 weeks.

Sponsors & Collaborators

  • Taizhou Mabtech Pharmaceutical Co.,Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2029-10-01
Completion
2030-06-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07595276 on ClinicalTrials.gov